파이로젠 검사 시장 보고서 : 제품, 검사 유형, 용도, 지역별(2025-2033년)

The global pyrogen testing market size reached USD 1.5 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 3.3 Billion by 2033, exhibiting a growth rate (CAGR) of 8.71% during 2025-2033. The market is propelled by the expanding pharmaceutical and biotechnology industries around the world, the increasing prevalence of chronic ailments such as heart diseases, cancer, and diabetes, and the launch of the new therapeutics and rising funding of research and development (R&D) activities.

Pyrogen Testing Market Trends:

Regulatory compliance and safety standards

The pyrogen testing market growth is significantly driven by the implementation of stringent regulatory frameworks by health authorities such as the FOOD and DRUGS ADMINISTRATION in the United States and the EUROPEAN MEDICINE AGENCY in Europe. The Association for the Advancement of Medical Instrumentation (AAMI) ST72:2002/R2010, Bacterial Endotoxins-Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing (AAMI ST72) are documents that describe the fundamental principles of the gel clot, photometric, and kinetic test methods, and recommend that appropriate components and finished products be tested for the presence of pyrogens and endotoxins. These regulations require rigorous safety testing of pharmaceuticals, medical devices, and biological products to ensure they are free of pyrogens, which can induce fever and pose severe risks to patients. As a result, manufacturers are incorporating pyrogen testing in their production processes.

Advancements in pharmaceuticals and biotechnology industries

The growth of the pharmaceutical and biotechnology sectors and the increasing biologics production is also creating a favorable pyrogen testing market outlook. Biologics, derived from living organisms are susceptible to contamination by pyrogens. According to IMARC GROUP, the global biologics market size reached US$ 349.6 Billion in 2023. Looking forward, the pyrogen testing market value is expected to reach US$ 699.5 Billion by 2032, exhibiting a growth rate (CAGR) of 7.8% during 2024-2032. As these industries expand, the requirement for sophisticated, reliable, and rapid pyrogen testing methods is also increasing. Moreover, this demand is leading to innovations in testing technologies, such as recombinant factor C (rFC) assays, which offer a synthetic alternative to traditional horseshoe crab blood-derived tests.

Developing healthcare infrastructure

The developing healthcare infrastructure in emerging economies and the increasing need for medical products that meet international safety standards, including pyrogen-free certifications is escalating the pyrogen testing demand. This expansion broadens the geographic market for pyrogen testing and compels local manufacturers to adopt advanced testing technologies to participate in global markets. Moreover, the development of healthcare systems and the increased healthcare spending is increasing the adoption and integration of advanced pyrogen testing processes. Besides, government authorities are also investing in the healthcare industry to promote public health. For instance, CENTER for DISEASE CONTROL and PREVENTION has awarded $3.2 billion to help state, local, and territorial jurisdictions across the United States strengthen their public health workforce and infrastructure. The $3.2 billion includes $3 billion from the AMERICAN RESCUE PLAN ACT for jurisdictions to recruit, retain, and train their workforce, including critical frontline public health workers such as epidemiologists, contact tracers, laboratory scientists, community health workers, and data analysts. The funding also includes $140 million from a new appropriation for jurisdictions to strengthen and revitalize their public health infrastructure.

Pyrogen Testing Market Segmentation:

Breakup by Product:

• Instruments
• Kits and Reagents
• Services

Kits and reagents accounts for the majority of the market share

Kits and reagents are user-friendly allowing for quick setup and execution of tests by laboratory personnel without the need for extensive specialized training. This convenience leads to faster turnaround times in testing. Besides, pre-packaged kits and reagents are more cost-effective than in-house testing methods. The costs associated with R&D, validation, and quality control of self-made tests can be prohibitively high, especially for smaller companies. Moreover, companies are acquiring and merging with other companies and launching new advanced products to expand their pyrogen testing market share. For instance, in March 2021, PromegaCorp. launched XpressAmp Direct amplification reagent.

Breakup by Test Type:

• In-vitro Tests
• LAL Tests
• Rabbit Tests
• Others

LAL tests hold the largest share of the industry

LAL tests are highly sensitive to bacterial endotoxins, capable of detecting them at very low levels. The sensitivity of these tests is crucial for ensuring the safety of pharmaceuticals and medical devices. Moreover, due to its proven reliability, the LAL test has become the standard method for endotoxin testing and is widely trusted by regulatory authorities and manufacturers. Besides, the LAL test is recognized and recommended by major regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Pharmacopoeia. For more than 30 years, FDA has accepted the use of a Limulus Amoebocyte Lysate (LAL) test for endotoxins in lieu of the rabbit pyrogens test.

Breakup by Application:

• Pharmaceutical and Biologics
• Medical Devices
• Others

Pharmaceutical and biologics represents the leading market segment

The biologics sector is growing rapidly, driven by advancements in biotechnology and an increasing focus on personalized medicine. This expansion contributes to a greater demand for pyrogen testing as more biologics enter research pipelines and commercial production. Moreover, pharmaceutical and biotechnology companies are investing heavily in research and development to create new drugs and biological products which necessitate rigorous safety testing, including pyrogen testing, to ensure that these innovations are safe for human use. For instance, California-based Amgen Inc. invests heavily in its research and development activities and its expenditure for research and development was US$ 4.8 Billion, US$ 4.2 Billion, and US$ 4.1 Billion, for 2021, 2020, and 2019, respectively, as per its 2021 company annual report. These factors are expanding the use of these testing in pharmaceutical and biologics thus creating a positive pyrogen testing market forecast.

Breakup by Region:

• North America
  • United States
  • Canada
• Asia-Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East and Africa

North America leads the market, accounting for the largest pyrogen testing market share

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America represents the largest regional market for pyrogen testing.

North America boasts an advanced healthcare infrastructure with a strong emphasis on regulatory compliance and patient safety. This infrastructure supports and demands high standards for medical products, influencing the need for pyrogen testing to ensure the safety of pharmaceuticals and medical devices. Besides, the healthcare expenditure in North America is among the highest in the world, with significant spending allocated to health innovation, including safety testing. According to the CENTERS FOR MEDICARE & MEDICAID SERVICES, the United States healthcare spending grew 4 pending grew 4.1% to reach $4.5 Trillion in 2022, faster than the increase of 3.2% in 2021. Besides, retail prescription drug spending increased 8.4% to $405.9 Billion in 2022, a faster rate than in 2021 when spending increased by 6.8%. This financial capability is escalating the need for pyrogen testing, across the healthcare and pharmaceutical sectors.

Competitive Landscape:

• The market research report has also provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the major market players in the pyrogen testing industry include Charles River Laboratories International Inc., Ellab A/S, Fujifilm Wako Pure Chemical Corporation (Fujifilm Holdings Corporation), Lonza Group AG, Merck KGaA, Microcoat Biotechnologie GmbH, Nelson Laboratories LLC (Sotera Health), North American Science Associates Inc., Pacific Biolabs Inc., Sanquin Reagents BV, Thermo Fisher Scientific Inc, Toxikon Corporation and Wuxi Apptec.
• The pyrogen testing market research report shows that leading companies are continually investing in research and development to improve existing products and create new, more efficient, and sensitive pyrogen testing methods. This includes the development of rapid tests and alternative methods like the monocyte activation test (MAT) and recombinant factor C (rFC) assay. Moreover, companies are increasingly focusing on expanding their presence in high-growth regions such as Asia-Pacific and Latin America as these regions offer significant opportunities due to their rapidly expanding pharmaceutical and medical device manufacturing sectors. According to IMARC Group, the India pharmaceutical market size reached US$ 54.6 Billion in 2023. Looking forward, it is expected to reach US$ 163.1 Billion by 2032, exhibiting a growth rate (CAGR) of 12.3% during 2024-2032. These values will continue to impact the pyrogen testing market statistics in the coming years.

Key Questions Answered in This Report:

• How has the global pyrogen testing market performed so far, and how will it perform in the coming years?
• What are the drivers, restraints, and opportunities in the global pyrogen testing market?
• What is the impact of each driver, restraint, and opportunity on the global pyrogen testing market?
• What are the key regional markets?
• Which countries represent the most attractive pyrogen testing market?
• What is the breakup of the market based on the product?
• Which is the most attractive product in the pyrogen testing market?
• What is the breakup of the market based on the test type?
• Which is the most attractive test type in the pyrogen testing market?
• What is the breakup of the market based on the application?
• Which is the most attractive application in the pyrogen testing market?
• What is the competitive structure of the market?
• Who are the key players/companies in the global pyrogen testing market?

Table of Contents

1 Preface

2 Scope and Methodology

• 2.1 Objectives of the Study
• 2.2 Stakeholders
• 2.3 Data Sources
  • 2.3.1 Primary Sources
  • 2.3.2 Secondary Sources
• 2.4 Market Estimation
  • 2.4.1 Bottom-Up Approach
  • 2.4.2 Top-Down Approach
• 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

• 4.1 Overview
• 4.2 Key Industry Trends

5 Global Pyrogen Testing Market

• 5.1 Market Overview
• 5.2 Market Performance
• 5.3 Impact of COVID-19
• 5.4 Market Forecast

6 Market Breakup by Product

• 6.1 Instruments
  • 6.1.1 Market Trends
  • 6.1.2 Market Forecast
• 6.2 Kits and Reagents
  • 6.2.1 Market Trends
  • 6.2.2 Market Forecast
• 6.3 Services
  • 6.3.1 Market Trends
  • 6.3.2 Market Forecast

7 Market Breakup by Test Type

• 7.1 In-vitro Tests
  • 7.1.1 Market Trends
  • 7.1.2 Market Forecast
• 7.2 LAL Tests
  • 7.2.1 Market Trends
  • 7.2.2 Market Forecast
• 7.3 Rabbit Tests
  • 7.3.1 Market Trends
  • 7.3.2 Market Forecast
• 7.4 Others
  • 7.4.1 Market Trends
  • 7.4.2 Market Forecast

8 Market Breakup by Application

• 8.1 Pharmaceutical and Biologics
  • 8.1.1 Market Trends
  • 8.1.2 Market Forecast
• 8.2 Medical Devices
  • 8.2.1 Market Trends
  • 8.2.2 Market Forecast
• 8.3 Others
  • 8.3.1 Market Trends
  • 8.3.2 Market Forecast

9 Market Breakup by Region

• 9.1 North America
  • 9.1.1 United States
    • 9.1.1.1 Market Trends
    • 9.1.1.2 Market Forecast
  • 9.1.2 Canada
    • 9.1.2.1 Market Trends
    • 9.1.2.2 Market Forecast
• 9.2 Asia-Pacific
  • 9.2.1 China
    • 9.2.1.1 Market Trends
    • 9.2.1.2 Market Forecast
  • 9.2.2 Japan
    • 9.2.2.1 Market Trends
    • 9.2.2.2 Market Forecast
  • 9.2.3 India
    • 9.2.3.1 Market Trends
    • 9.2.3.2 Market Forecast
  • 9.2.4 South Korea
    • 9.2.4.1 Market Trends
    • 9.2.4.2 Market Forecast
  • 9.2.5 Australia
    • 9.2.5.1 Market Trends
    • 9.2.5.2 Market Forecast
  • 9.2.6 Indonesia
    • 9.2.6.1 Market Trends
    • 9.2.6.2 Market Forecast
  • 9.2.7 Others
    • 9.2.7.1 Market Trends
    • 9.2.7.2 Market Forecast
• 9.3 Europe
  • 9.3.1 Germany
    • 9.3.1.1 Market Trends
    • 9.3.1.2 Market Forecast
  • 9.3.2 France
    • 9.3.2.1 Market Trends
    • 9.3.2.2 Market Forecast
  • 9.3.3 United Kingdom
    • 9.3.3.1 Market Trends
    • 9.3.3.2 Market Forecast
  • 9.3.4 Italy
    • 9.3.4.1 Market Trends
    • 9.3.4.2 Market Forecast
  • 9.3.5 Spain
    • 9.3.5.1 Market Trends
    • 9.3.5.2 Market Forecast
  • 9.3.6 Russia
    • 9.3.6.1 Market Trends
    • 9.3.6.2 Market Forecast
  • 9.3.7 Others
    • 9.3.7.1 Market Trends
    • 9.3.7.2 Market Forecast
• 9.4 Latin America
  • 9.4.1 Brazil
    • 9.4.1.1 Market Trends
    • 9.4.1.2 Market Forecast
  • 9.4.2 Mexico
    • 9.4.2.1 Market Trends
    • 9.4.2.2 Market Forecast
  • 9.4.3 Others
    • 9.4.3.1 Market Trends
    • 9.4.3.2 Market Forecast
• 9.5 Middle East and Africa
  • 9.5.1 Market Trends
  • 9.5.2 Market Breakup by Country
  • 9.5.3 Market Forecast

10 SWOT Analysis

• 10.1 Overview
• 10.2 Strengths
• 10.3 Weaknesses
• 10.4 Opportunities
• 10.5 Threats

11 Value Chain Analysis

12 Porters Five Forces Analysis

• 12.1 Overview
• 12.2 Bargaining Power of Buyers
• 12.3 Bargaining Power of Suppliers
• 12.4 Degree of Competition
• 12.5 Threat of New Entrants
• 12.6 Threat of Substitutes

13 Price Analysis

14 Competitive Landscape

• 14.1 Market Structure
• 14.2 Key Players
• 14.3 Profiles of Key Players
  • 14.3.1 Charles River Laboratories International Inc.
    • 14.3.1.1 Company Overview
    • 14.3.1.2 Product Portfolio
    • 14.3.1.3 Financials
    • 14.3.1.4 SWOT Analysis
  • 14.3.2 Ellab A/S
    • 14.3.2.1 Company Overview
    • 14.3.2.2 Product Portfolio
  • 14.3.3 Fujifilm Wako Pure Chemical Corporation (Fujifilm Holdings Corporation)
    • 14.3.3.1 Company Overview
    • 14.3.3.2 Product Portfolio
  • 14.3.4 Lonza Group AG
    • 14.3.4.1 Company Overview
    • 14.3.4.2 Product Portfolio
    • 14.3.4.3 Financials
    • 14.3.4.4 SWOT Analysis
  • 14.3.5 Merck KGaA
    • 14.3.5.1 Company Overview
    • 14.3.5.2 Product Portfolio
    • 14.3.5.3 Financials
    • 14.3.5.4 SWOT Analysis
  • 14.3.6 Microcoat Biotechnologie GmbH
    • 14.3.6.1 Company Overview
    • 14.3.6.2 Product Portfolio
  • 14.3.7 Nelson Laboratories LLC (Sotera Health)
    • 14.3.7.1 Company Overview
    • 14.3.7.2 Product Portfolio
  • 14.3.8 North American Science Associates Inc.
    • 14.3.8.1 Company Overview
    • 14.3.8.2 Product Portfolio
  • 14.3.9 Pacific Biolabs Inc.
    • 14.3.9.1 Company Overview
    • 14.3.9.2 Product Portfolio
  • 14.3.10 Sanquin
    • 14.3.10.1 Company Overview
    • 14.3.10.2 Product Portfolio
  • 14.3.11 Thermo Fisher Scientific Inc
    • 14.3.11.1 Company Overview
    • 14.3.11.2 Product Portfolio
    • 14.3.11.3 Financials
    • 14.3.11.4 SWOT Analysis
  • 14.3.12 Toxikon Corporation
    • 14.3.12.1 Company Overview
    • 14.3.12.2 Product Portfolio
  • 14.3.13 Wuxi Apptec
    • 14.3.13.1 Company Overview
    • 14.3.13.2 Product Portfolio
    • 14.3.13.3 Financials